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The Swiss drug giant Novartis plans to give away up to 250,000 bottles of its new liquid children’s medicine, Triaminic Fever Reducer Pain Reliever, in an effort to woo parents frustrated by a nationwide recall and shortage of a competing product — liquid children’s Tylenol.

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Both the Tylenol, made by a unit of Johnson & Johnson, and the new Triaminic product contain acetaminophen, a drug that mitigates pain and fever. Novartis valued its marketing program, which offers rebates to consumers who buy the Triaminic fever medication from Aug. 2 through Aug. 8, at $1.5 million . Triaminic, a 50-year-old brand, already makes children’s cough and cold medicines.

Industry analysts said Novartis had made a strategic move to gain market share at an opportune moment.

McNeil Consumer Healthcare, the Johnson & Johnson unit, recalled an estimated 136 million bottles of liquid children’s Tylenol and other pediatric medications in April because of manufacturing deficiencies. McNeil, to make an upgrade, has closed a plant in Pennsylvania that made the drugs involved in the recall, causing a shortage of children’s medications at many drugstores.

“If you are going to take on children’s Tylenol, now is the time to do it,” said Mick Kolassa, the chairman of Medical Marketing Economics, a firm that consults with drug makers about product marketing and pricing. “It’s a beautiful opportunity. There’s concern. There’s a shortage. There’s a wide opening in the marketplace.”

Sales at McNeil fell $200 million in the second quarter because of the recall and plant shutdown, Johnson & Johnson executives said last week during a conference call with investors. They estimated that the problems at McNeil would reduce annual sales by about $600 million.

McNeil brands like Tylenol, Motrin and Benadryl have long dominated the market for children’s medicines. But many parents were frustrated by the scope of the recall, said Dr. Jeannette Levenstein, a pediatrician in Encino, Calif., who has written about the issue on the parenting Web site strollertraffic.com And, she added, they have been frustrated by a dearth of generic alternatives.

“It certainly has put a dent in our parents’ capability to keep their kids’ cool and their own sensibilities in line when they are clamoring for generics and they are nowhere to be found,” Dr. Levenstein wrote in an e-mail on Wednesday.

Now Novartis is hoping to build brand loyalty with its new children’s fever and pain relief syrup.

The company was already developing a fever product before the Tylenol recall. But the company sped up the introduction of its product to fill a void in the marketplace, a company spokeswoman said.

“We accelerated the timing because, given the lack of availability of some over-the-counter children’s analgesic products, we felt it was an important time to offer parents a reliable fever reducer and pain reliever product for their children from a trusted brand,” Julie Masow, a spokeswoman for Novartis Consumer Health, wrote in an e-mail.

The Triaminic giveaway campaign uses the slogan “restock your medicine cabinet,” a phrase intended to remind people of the McNeil products they may have thrown out because of the recall, Mr. Kolassa, the industry consultant, said.

“It’s saying, O.K., you’ve gotten rid of the Tylenol because of the problems and now here’s a chance to replace it,” Mr. Kolassa said. “It’s a savvy move.”

Even so, some industry analysts said it was difficult to quantify the size of the market opportunity for products that compete with children’s Tylenol.

“Novartis is trying to take advantage of this opportunity to capture a portion of the market left vacant with a brand that will reassure parents,” two analysts at Raymond James wrote Wednesday in a note to investors. But consumers could turn to generic alternatives, the analysts wrote, so “the impact for Novartis is tough to evaluate at this stage.”

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In an unusual move, a state government is developing regulations meant to stop doctors from prescribing higher doses of powerful — and often dangerous — pain killers for patients who are not benefiting from them.

Dr. Alex Cahana, a pain specialist, is involved in devising regulations to stem the use of prescribed narcotics in Washington State.

The effort, in Washington State, represents the most sweeping attempt yet to stem what some experts see as the excessive use of prescribed narcotics, and it is being closely watched by medical professionals elsewhere. Among other things, Washington would apparently become the first state that would require a doctor to refer patients on escalating doses of pain killers for evaluation if they were not improving.

Experts in pain treatment and drug abuse prevention say the growing use of long-acting pain killers like OxyContin, fentanyl and methadone has been a crucial factor in a nationwide epidemic of overdose deaths, largely from the abuse of such drugs.

Nationwide, fatalities from prescription drug overdoses are the second-leading cause of accidental death behind car accidents and, in some states, are the leading cause, according to the Centers for Disease Control and Prevention.

Last year, narcotic pain killers accounted for 7 percent of all prescribed drugs, and the number of patients annually taking long-acting versions of these medications has increased about 30 percent over the last decade.

But a long-running debate has thwarted efforts to address the problem both at the federal and state level.

Drug makers and patient groups have complained that new restrictions would unfairly punish pain sufferers who rely on the drugs, while others, including some doctors and regulators, have argued that the drugs are potentially so dangerous that they need to be even more tightly controlled.

However, the Washington State initiative appears to reflect a growing view that the status-quo is no longer acceptable. Last Friday, an advisory panel to the Food and Drug Administration overwhelmingly rejected an agency proposal to better control drugs like OxyContin as too weak because it did not mandate special training for doctors who prescribe such medications.

The effort in Washington is also directed at controlling how doctors use narcotics to treat legitimate pain patients, not at people who illegally obtain the drugs for recreational use. While many patients benefit from pain killers, there is growing evidence from studies, including one in Washington State, that others suffer significant side effects, including lethargy, increased sensitivity to pain and, in the most severe instances, potentially fatal overdoses.

“This is not just about addicts but little old ladies with arthritis starting to die because of this kind of medical practice,” said Dr. Alex Cahana, a pain specialist involved in devising the regulations in Washington State.

Lawmakers in Washington State adopted voluntary narcotics use guidelines three years ago, but a statewide survey last year indicated that many doctors were not following them and about half were not even aware of them.

At the direction of the Washington State Legislature, a panel of doctors, nurses, regulators and others are compiling a set of medical practices that physicians and other prescribers would be legally expected to follow when treating patients with long-term pain from causes other than cancer.

The regulations would not affect how narcotics are used to treat patients with cancer or those at the end of life because experts agree that such patients should receive as much pain medication as necessary.

The panel is expected to require that, among other things, doctors refer patients to a pain specialist for review when their daily medication increases to a specified dosage level and they do not show improvement. The specialist can then determine whether to continue the drug, reduce it or use other treatments like physical therapy.

Recently, the Centers for Disease Control issued a similar recommendation to doctors.

Pain specialists and regulators in Washington State said they believed that the requirements were essential because doctors were giving high daily dosages of powerful drugs for ailments like back pain for far too long without evidence that the medications worked.

The law that created the new regulatory effort in Washington State did not propose specific sanctions or penalties. However, officials there said that a doctor who chose to ignore the new rules could face sanctions from state licensing boards, including potentially losing the right to practice. The company that makes OxyContin, Purdue Pharma, lobbied against the law, saying the new regulations could deprive patients of appropriate treatment.

The initiative sprang out of the efforts of Dr. Cahana and two other people, including a Washington State representative, James C. Moeller, who is also a substance abuse counselor.

Mr. Moeller, who works at a facility in Vancouver, Wash., run by Kaiser Permanente, said he had treated a steady procession of patients in recent years, nearly all of them young and physically dependent or psychologically addicted to high dosages of pain killers.

In the process, Mr. Moeller said, he realized that many doctors who prescribed such drugs had little training in either pain management or substance abuse. So, wearing his legislator’s hat, he drafted a bill to require doctors to take a training course to prescribe narcotics.

He said he quickly encountered opposition to the idea from a professional group that represented doctors. At that point, Dr. Cahana and the third man, Dr. Gary M. Franklin, the medical director of the state’s Department of Labor and Industries, stepped in.

The two doctors, through different routes, had arrived at the same conclusion — that too many pain patients were getting drugs at dosages that were too high for too long.

“There is a dissonance in not recognizing the nexus between poor pain management and the hyperconsumption of opioids,” said Dr. Cahana, who works at the University of Washington Medical Center in Seattle, using a medical term for narcotic pain killers like OxyContin.

For his part, Dr. Franklin, whose department oversees the state’s workers’ compensation program, said he had long seen the problem play out among claimants. “Injured workers were coming into the system with low back pain and dying two or three years later” from drug overdoses, he said.

This year, Dr. Cahana and Dr. Franklin testified during a legislative hearing on the proposed training requirement, suggesting that legislation should instead require a set of medical practices based on the best available evidence. Dr. Franklin said that a draft of rules would probably be finished by this fall and that the new regulations would be in place by next year.

A major hurdle to making the program work is the lack of pain management specialists, particularly in rural areas of the state, where patients on the narcotics could be referred for evaluation. Dr. Franklin said the state hoped to increase the use of telephone consultations as well as help to finance the training of doctors in pain treatment.

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Migraines and the Menstrual Cycle

by admin on July 28, 2010

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Can Migraines Damage the Brain?

by admin on July 28, 2010

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When the Robert Wood Johnson Foundation decided in 1991 to take on Joe Camel, it became the nation’s largest private funding source for fighting smoking. The foundation spent $700 million to help knock the cartoon character out of advertisements, finance research and advocacy for higher cigarette taxes and smoke-free air laws and, ultimately, to aid in reducing the nation’s smoking rate almost by half.

Michelle Obama had a vegetable garden planted at the White House and is leading a new campaign against childhood obesity.

The Robert Wood Johnson Foundation took on Joe Camel in the 1990s. It is now spending $500 million to battle childhood obesity.

But a few years ago, the Johnson foundation, based in Princeton, N.J., added another target to its mission, pledging to spend $500 million in five years to battle childhood obesity. As the antiobesity financing rose to $58 million last year, a new compilation from the foundation shows, the organization’s antismoking grants fell to $4 million.

The steep drop-off in private funds illustrates the competition under way for money as public health priorities shift. In the race for preventive health care dollars, from charities and from federal and state government sources, the tobacco warriors have become a big loser. And the nation’s battle to shed pounds has in its corner the White House, with Michelle Obama leading a new campaign against childhood obesity. Shortly after the first lady kicked off the “Let’s Move” program, the administration awarded more funds to fight obesity than tobacco through two big new money sources for preventive health. The funds, totaling $1.15 billion, came from economic stimulus and health care reform legislation. They still provided more than $200 million for tobacco-use prevention, but much more to grapple with obesity.

The changes in financing are also evident across the country. State governments have used tobacco’s billions to balance their budgets while cutting $150 million from antitobacco programs over the last two years. On the airways, obesity public service announcements are lining up while a “Truth” campaign about tobacco languishes for lack of money.

“Don’t forget tobacco,” pleaded a commentary this month in The New England Journal of Medicine.

One in five Americans still smokes.

But one in three is obese.

And competition for attention is growing between the two biggest issues in public health.

“I don’t see anybody else rushing into the vacuum,” says Dr. Steven A. Schroeder, former president of the Johnson foundation. “The sad thing is, smoking, despite all the harm it does, is left pretty much an orphan.”

Dr. James S. Marks, senior vice president of the foundation, said it had to pick its targets. “When we made the commitment to spend $500 million in obesity, we made the commitment to see if we couldn’t do for childhood obesity what we did in tobacco,” he said.

The decline in state funding to prevent smoking has distressed advocates. The 1998 Tobacco Master Settlement Agreement between 46 states and cigarette companies provided more than $200 billion through 2025. For a while it financed preventive programs like the “Truth” media campaign from the antismoking group American Legacy Foundation. But as states used money elsewhere, “Truth” spending declined, to a low of $35 million last year from $104 million in 2000.

“The industry outspends us in a day what we spend in a year,” said David Dobbins, chief operating officer of Legacy.

And even as states were raising taxes on cigarettes to record levels — a proven way to deter smoking — they were shifting that revenue to general funds. Both tobacco industry analysts and antismoking groups say that states have become addicted to tobacco money but are using less of it for prevention efforts.

“Overall funding on tobacco control is down because of dramatic cuts in state spending in recent years,” Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in an interview. “In the last several years we’ve seen the rapid progress in both adult and youth smoking rates slow to a crawl largely because of a decline in overall spending at the state level on tobacco prevention and cessation.”

State funding for antitobacco programs dropped to $567 million last year, from $717 million two years earlier, a 21 percent cut, according to an advocacy groups’ report titled “A Broken Promise to Our Children.”

While the federal government has made up for some of the state decline in antitobacco funding, it is spending even more on antiobesity efforts. And despite politic statements, there is undeniable competition for public health money.

“In our reaction to the obesity epidemic, sometimes we have taken our eye off other issues,” Terry F. Pechacek, of the Centers for Disease Control and Prevention office on smoking and health, said in a recent interview.

But Dr. Howard K. Koh, assistant secretary for health, focused on what he said was unprecedented funding from the federal government for both issues.

“Rather than pitting one disease against another, we want to uphold comprehensive prevention policies,” he said in a phone interview. Dr. Koh said the administration was directing $722 million to tobacco control and research this year and $821 million to obesity control and research.

The tobacco funding includes industry fees to set up a new regulatory office in the Food and Drug Administration. About half of the tobacco funding and most of the obesity funding is in research financed by the National Institutes of Health, illustrating the relative newness of obesity research.

In addition, the 2009 economic stimulus package included $650 million for “prevention and wellness strategies.” In February, state smoking quit lines received more than $44 million. In March, obesity programs received 62 percent of a $372 million award while tobacco programs received 38 percent.

Kathleen Sebelius, secretary of health and human services, made the awards in March a month after joining with Mrs. Obama to help kick off the first lady’s campaign against childhood obesity.

Stanton A. Glantz, director of the Center for Tobacco Control Research and Education at the University of California, San Francisco, asked, “Given that tobacco kills four times as many people as obesity does, why is the government putting more money into obesity?”

Kenneth E. Thorpe, a professor of health policy and obesity researcher at Emory University in Atlanta, defended the shifting resources, noting that obesity rates had doubled since 1985. And health problems related to being overweight now account for about 30 percent of the increase in health care spending, he said.

“The smoking rate, fortunately, has been coming down. Not far enough, but that’s moving in the right direction. Obesity is moving in the wrong direction,” he said.

Congress also created a $15 billion, 10-year Prevention and Public Health Investment Fund as a part of health care reform.

The first $250 million went in June to increase the number of primary care doctors, nurses and other health care workers — more to battle sickness than promote wellness, critics said. Jeff Levi, executive director of the Trust for America’s Health, a nonprofit advocacy group, said he was disappointed that the money was “diverted.”

Dr. Koh, the assistant secretary, who is an oncologist and formerly a Harvard professor and Massachusetts state health chief, said, “It was a one-time investment and we need those providers to deliver preventive services.”

Out of the second $250 million, $16 million went in June to obesity prevention and $16 million to tobacco cessation. Parts of other funds could be used for those purposes. But the nation’s leading antismoking groups had written Ms. Sebelius in April asking for about 30 percent of the total, which would have been $150 million.

Next year the prevention fund from health care reform rises to $750 million and to $1 billion after that, so the dueling organizations fighting smoking or obesity will be competing for a much larger pot of money.

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AUSTIN, Tex. — There are more uninsured residents of Texas — 6.1 million and counting — than there are people in 33 states. The state’s elected officials might be expected, therefore, to cheer a federal health care law that is likely to deliver billions of dollars from Washington to Austin and cover millions of low-income Texans.

Gov. Rick Perry is working to turn back the health care law even as Texas policy makers work to put its provisions into effect.

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Instead, the Republican political leadership has greeted the law and its anticipated costs with open hostility, leaving policy makers to move forward with a complex set of changes even as the governor, attorney general and ranking legislators rage against it. The same awkward dichotomy exists in many of the 21 states that are challenging the health reform act’s constitutionality, but are nonetheless required to follow it while their lawsuits meander through the courts.

In Austin, legislative hearings and agency planning sessions proceed despite Gov. Rick Perry’s vow to fight “on every front available” against a law that he characterizes as “socialism on American soil.” Bureaucrats apply for federal grants and collaborate with the Obama administration at the same time that Attorney General Greg Abbott strategizes to eviscerate the law in court.

“Sometimes it seems a little schizophrenic,” acknowledged State Representative John M. Zerwas, a Republican who favors the law’s repeal but also leads a House committee that seeks to maximize its benefits to Texas. “There are plenty of laws out there that I might not agree with. But if the law of the land says we have to do it, the last thing I want is for Texas to not be prepared or not put things in place to comply.”

The antipathy toward the law in Texas is rooted in deeply conservative politics that have been further stirred up in a gubernatorial election year. Because one in four Texans is uninsured, the highest ratio in the country, the law’s advocates argue that Texas stands to gain as much as any state. But leaders in Austin are focused on the fiscal threat it poses, which they estimate could cost the state $27 billion in the 10 years beginning in 2014.

“You can say a chicken in every pot, a car in every garage and health care for all, if taken in isolation,” said Mr. Abbott, a leader among the Republican attorneys general who are suing the federal government in Florida. “But none of those are good things if it requires breaking the Constitution and breaking the bank to do it.”

States share in the cost of Medicaid, the government insurance program for the poor, and the new health law will vastly expand eligibility by offering coverage to childless adults

State agency leaders said politics had not interfered to date with that task, or with new requirements to create a health insurance exchange and oversee strict regulations on health insurers.

“I don’t have any sense that I’m being held back in any way,” said Billy Millwee, the state Medicaid director.

That view was echoed by Thomas M. Suehs, the commissioner of health and human services, who said the governor “expects me to implement the federal law in the most cost-effective, efficient manner.”

Mr. Perry, who is seeking re-election to a third full term after filling George W. Bush’s seat, declined to be interviewed.

Obama administration officials, while noting the incongruity, said they had been impressed that politically antagonistic states like Texas were complying with, and taking full advantage of, the new law. The Texas Department of Insurance, for instance, has applied for a planning grant to create a more muscular process for reviewing proposed premium increases, a White House priority.

“That’s sort of the operational norm in Texas,” said F. Scott McCown, executive director of the Center for Public Policy Priorities, which advocates for safety-net programs in the state. “Your leadership may be railing against Washington, but federal supremacy still requires that the people in the trenches get the work done.”

That dynamic may be tested down the road as states decide how aggressively to market the Medicaid expansion that begins in 2014, when most Americans will be required to obtain coverage.

Texas traditionally has set among the country’s most restrictive Medicaid eligibility thresholds. This has limited its Medicaid rolls, as have burdensome application requirements, outmoded computers, inadequate staffing and difficulties in signing up children born to illegal immigrants.

Mr. Perry, whose antagonism toward Washington is central to his political persona, would seem to be in tune with public opinion. Sixty percent of Texans questioned in May for a University of Texas/Texas Tribune poll said they opposed the health care law. Only 28 percent said they liked it.

The Democratic nominee for governor, Mayor Bill White of Houston, has not made an issue of Mr. Perry’s approach. He said in an interview that he also opposed the health care law because of its potential impact on the federal deficit.

In late April, Mr. Perry announced that Texas would not establish the temporary high-risk insurance pool required by the law, leaving that task to the federal government. Twenty other governors made the same choice, arguing that the new law did not provide enough money for the pools, and that states would be left holding the bag.

Some Democrats find the position inconsistent. “You can’t run around saying the federal government wants to take over Texas, but then when we have an opportunity to do it ourselves leave it to the federal government,” said State Representative Garnet F. Coleman, a Democrat.

Democrats also accuse the Perry administration of producing a sticker-shock cost estimate for the state’s share of Medicaid expansion. To come up with his 10-year projection, Mr. Suehs skipped the law’s first four years, when states bear little cost. He also assumed an increase in enrollment that some analysts say is inflated.

The commissioner projects that 2.3 million people will be added to the Medicaid rolls by 2023, nearly doubling the current enrollment of 3.1 million. Thanks largely to job losses during the economic downturn, enrollment has surged 12 percent in the past year.

Mr. Suehs and other state officials worry about a severe shortage of doctors who are willing to accept low Medicaid payments, which the state is about to cut by 1 percent. They also are concerned about the continuing strain on hospitals from treating an estimated 800,000 uninsured illegal immigrants, who will not be eligible for subsidized coverage under the new law.

But among the reasons the law could be expensive for Texas is the state’s past failure to enroll many of those already eligible for Medicaid. Going forward, Washington will pay a much smaller share of the cost for those recipients than for those who gain coverage because of expanded eligibility.

The federal government would still pay nearly 90 percent of the state’s total costs. But that is providing little comfort in a tax-averse Capitol that faces an $18 billion shortfall in its budget over the next two years.

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Following a Script to Escape a Nightmare

by admin on July 27, 2010

THERAPY Computers track data at the Maimonides clinic in Albuquerque.

ALBUQUERQUE — Her car is racing at a terrifying speed through the streets of a large city, and something gruesome, something with giant eyeballs, is chasing her, closing in fast.

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UNTANGLING Marcia Naughton, who has post-traumatic stress disorder, was wired with sensors before going to bed at the clinic.

It was a dream, of course, and after Emily Gurule, a 50-year-old high school teacher, related it to Dr. Barry Krakow, he did not ask her to unpack its symbolism. He simply told her to think of a new one.

“In your mind, with thinking and picturing, take a few minutes, close your eyes, and I want you to change the dream any way you wish,” said Dr. Krakow, founder of the P.T.S.D. Sleep Clinic at the Maimonides Sleep Arts and Sciences center here and a leading researcher of nightmares.

And so the black car became a white Cadillac, traveling at a gentle speed with nothing chasing it. The eyeballs became bubbles, floating serenely above the city.

“We call that a new dream,” Dr. Krakow told Ms. Gurule. “The bad dream is over there” — he pointed across the room — “and we’re not dealing with that. We’re dealing with the new dream.”

The technique, used while patients are awake, is called scripting or dream mastery and is part of imagery rehearsal therapy, which Dr. Krakow helped develop. The therapy is being used to treat a growing number of nightmare sufferers. In recent years, nightmares have increasingly been viewed as a distinct disorder, and researchers have produced a growing body of empirical evidence that this kind of cognitive therapy can help reduce their frequency and intensity, or even eliminate them.

The treatments are controversial. Some therapists, particularly Jungian analysts, take issue with changing nightmares’ content, arguing that dreams send crucial messages to the waking mind.

Nightmares are important because they “bring up issues in bold print,” said Jane White-Lewis, a psychologist in Guilford, Conn., who has taught about dreams at the Carl Jung Institute in New York.

While Dr. White-Lewis acknowledged that she does not treat patients suffering from severe trauma, she said that if a nightmare is eliminated, “you lose an opportunity to really get some meaning out of it.” Changing eyeballs into bubbles, she added, might have robbed Ms. Gurule of the chance to find out what the eyeballs were trying to tell her.

Nightmares have fascinated and perplexed people for centuries, their meaning debated by therapists and analysts of all schools of thought, their effects so powerful that one terrifying nightmare can affect a person for a lifetime.

A nightmare is “a disturbing dream experience which rubs, bites and sickens our soul, and has an undercurrent of horsepower, lewd demons, aggressive orality and death,” Dr. White-Lewis wrote in “In Defense of Nightmares,” her contribution to a 1993 book of essays about dreams.

From 4 to 8 percent of adults report experiencing nightmares, perhaps as often as once per week or more, according to sleep researchers. But the rate is as high as 90 percent among groups like combat veterans and rape victims, Dr. Krakow said. He said treatment for post-traumatic stress needed to deal much more actively with nightmares.

He and other clinicians are increasingly using imagery rehearsal therapy, or I.R.T., to treat veterans and active-duty troops in the Iraq and Afghanistan wars. Last month, Dr. Krakow conducted a workshop on imagery rehearsal and other sleep treatments for 65 therapists, sleep doctors and psychiatrists, including many working with the military. And the technique has drawn more attention from other researchers in the last several years. Anne Germain, an associate professor of psychiatry at the University of Pittsburgh School of Medicine, is comparing two treatments — behavioral therapy, including imagery rehearsal, and the blood-pressure drug prazosin, which has been found to reduce nightmares.

Preliminary results from a study of 50 veterans showed that both treatments were effective in reducing nightmares and symptoms of P.T.S.D., she said, though they differed from patient to patient. She is continuing to study what factors may lead to those differences.

Deirdre Barrett, a psychologist at Harvard Medical School who is an expert on dream incubation, inducing dreams to resolve conflicts , and on the connection between trauma and dreams — said she was struck by the growing interest in nightmares as a result of war trauma and torture.

“Within the community of psychologists who have put an emphasis on dreams it used to be about interpretation,” she said. “And now therapists are getting the message that you can influence dreams, ask dreams about particular issues and change nightmares.”

And Hollywood has just produced its own spin on the idea of controlling dreams, with the release earlier this month of “Inception” a thriller whose plot swirls through the darkest layers of the dream world. Underlying the story is the concept of lucid dreaming, another technique used by clinicians to help patients afraid of their dreams understand that they are dreaming while a dream is in progress. Dr. Barrett supports the use of Dr. Krakow’s technique, although she said that ideally the nightmare work should be integrated with psychiatry and behavioral therapies to treat the underlying condition.

Still, Dr. Barrett said, “Barry has made a huge contribution by getting the numbers, getting the statistics and getting the proof that it can work.”

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HOPE AMID ANGUISH Francis Byarugaba, 32, was too weak to stand in line as he waited to be seen at a clinic in April in Kanyantorogo, Uganda.

VIENNA — The best AIDS-prevention news in years was released here last week at a world conference on the disease: a vaginal gel, called a microbicide, that can be used without a man knowing it, gave women a 39 percent chance of avoiding infection with the deadly virus.

The new H.I.V. protection gel for women.

VIENNA A wide-angle shot of activists demanding more funds for fighting AIDS during a global conference last week.

Thirty-nine percent is, obviously, not perfect, though the women in the South African trial who used the gel most faithfully did better, achieving 54 percent protection.

After more than a dozen microbicide failures, it was a huge relief, and led to cheering and standing ovations for the researchers here.

“This is a field that’s known a lot of pain,” said Catherine Hankins, chief scientific adviser for Unaids, the United Nations’ AIDS-fighting agency.

There was general relief that the data was not as shaky as that of an AIDS vaccine trial released in September.

“There’s a certain feeling of ease and pleasure for me as a scientist that any way you slice the data, it’s statistically significant,” said Dr. Anthony S. Fauci, a top AIDS expert in the United States government, which paid most of the trial’s costs.

There was an unexpected bonus: the gel protected women even better against genital herpes. (The investigators were not sure why, but it contained tenofovir, an antiviral drug, and AIDS and herpes are both viral.)

Now experts are pondering the many questions raised by the news.

How much more testing will it need to win approval from drug regulators?

Would more than 1 percent tenofovir in the gel, or a two-drug mix, work better?

Can it be made cheaply enough for poor countries? (The gel costs 2 cents a dose, but the applicators are 40 cents because they are patented and were frequently redesigned to be more comfortable.)

The women had sex an average of five times a month, and were instructed to insert gel before and afterward. Would one dose, which would be easier and cheaper, work just as well?

Will it protect prostitutes, who have sex with many men in succession? Is it safe enough to use daily?

Can pregnant women use it? (Some women got pregnant and gave birth, but were taken off the gel quickly to reduce any risk.)

Would women who use it but got infected anyway develop hard-to-cure drug-resistant infections?

And, although it was tested on poor African women, might it appeal to Western women, some of whom might worry more about herpes than AIDS?

Might it also work for anal sex, and protect gay men?

The investigators and other experts said they had only partial hints of answers, but most were encouraging.

And, given that this is AIDS research, which inevitably creates controversy, some hard questions were raised.

If it was known after the first year that the gel was working, why wasn’t the trial stopped?

And what will happen to the 889 African women who, in the words of Mark Harrington, an AIDS activist, “put their bodies on the line for this study”? Would they be able to keep getting the product that might have saved their lives?

Some questions were easy, said Dr. Salim Abdool Karim, a study leader and professor of epidemiology at both the University of KwaZulu-Natal in South Africa and Columbia University.

The price of a dose could fall below that of a condom because the applicators are just molded plastic and, without patents restrictions, “the Chinese could make them for half a penny,” he said.

Others, like what drug and dose combinations are best and safest, must be tackled in future trials. A complex multination trial of several methods, including microbicide, is due to end in 2013, but a rapid new one may be designed as quickly as possible.

Globally, more than a million women a year die of AIDS, so speed is important.

The gel has never been tested in men, but has protected monkeys given anal doses of the simian version of the virus. Dr. Karim said samples he took found that tenofovir in the women’s vaginal linings had migrated to their rectal linings too, meaning they might also have been protected against anal sex.

“The tissue between the two is very thin,” he said.

Using a gel rather than a pill meant the drug infused the genital tracts but hardly reached the blood. That lowered the chances that a woman who got infected anyway would develop tenofovir-resistant virus, experts said.

No woman developed it, but they were tested so often that the virus would have had little time to mutate.

Dr. Kevin A. Fenton, director of the AIDS division of the Centers for Disease Control and Prevention, said the one-two AIDS-and-herpes punch “could make it more attractive to American women.”

It’s not clear whether men would like gels, and tenofovir pills are being tested in uninfected gay men, but the results “are a real shot in the arm to the field,” he said.

The trial was not stopped early, Dr. Karim said, because the independent review board that could have done so wanted results so overwhelming that they would have equaled the results of two generally favorable trials, “and we didn’t achieve that level of efficacy.”

Dr. Sheena McCormack, a British microbicide researcher, recalled penicillin tests of 70 years ago. Those researchers gave it to their sickest patients, not a random sample, and it still worked astonishingly well. This, she said, more resembled trials of circumcision as an AIDS preventive, which took three to be convincing.

What happens to the 889 women is unclear. Dr. Quarraisha Abdool Karim, Dr. Karim’s wife and research partner, said more gel needed to be made and she hoped to enroll them quickly in a new trial so they could get it.

Mr. Harrington said he thought they ought to have a choice of being in another trial or just getting the gel indefinitely, even though it is not legally approved by any drug-regulatory agency yet.

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One of my big headaches at the moment is a patient — call him Ralph — who appears to be one of the most successful small-time alchemists in all of New York.

He creates gold from dross modern-style, filling his prescriptions every month like clockwork and then selling the unopened bottles for hundreds of dollars each on a street corner somewhere. A Medicaid card financed at great expense by his fellow citizens should really not be used as a cash card, and shortly I plan to help dismantle his enterprise.

But sitting in a darkened auditorium the size of a football field in Vienna last week, one of the 20,000 attendees at the big biennial international AIDS conference, I began to think about Ralph in a new light.

It’s all about global access to lifesaving drugs these days, and things are looking up in a ‘been down so long’ sort of way. Against all odds, more than 5 million H.I.V. infected people worldwide are on treatment, a minority of those who need it, but still a creditable start. Whether the international funds that created this momentum will sustain it is another story, already competing health agendas are draining some of it away.

Knowing Ralph as I do, I can easily predict his reaction to this and all similar statistics from the rest of the world: he shrugs, he smiles. “What’s that got to do with me?”

In the past, I might have agreed with him. It can be remarkably difficult to make any solid mental and emotional connection between AIDS in wealthy countries and the roiling new infections of the third world. Here, it is all about fine tuning regimens, learning to cope with the drug side effects long term. There, it is all blood and triage, high-energy battlefield medicine. There, it is all about saving lives, and here we have Ralph, selling his life away.

Ralph — middle-aged, with a bald spot and a paunch — was born in New York and has lived here all his life. He worked at a blue-collar job in Midtown Manhattan until technology made his job obsolete. He has been a recreational drug user for decades and developed AIDS at least 15 years ago. The fact that he is still alive today is testament to the fact that some of the truisms about his disease are actually not uniformly true: it doesn’t kill everyone, at least not right away, even if they habitually play fast and loose with their meds.

As far as I can figure out, Ralph takes his pills for a few months out of the year. I got records from the last clinic he was asked to leave when his entrepreneurial tendencies became clear, and his blood tests are fascinating. Some months they look pretty good, other months they are terrible, with sky-high levels of virus and almost no immune cells.

I assume those are the months when his bottles of a particularly valuable combination AIDS pill — one of my other patients tells me each bottle will fetch many hundreds of dollars on the black market — move from Ralph’s possession to someone else’s.

I wish I knew more about the black market for prescription drugs in our country. It is one of the many germane items that have yet to make it into the continuing medical education curricula. Most of what I know comes from patients, with a few facts from the odd phone conversation with the Medicaid fraud unit. It seems that the exuberant market for narcotics and sedatives is mostly domestic — these pills have become the most abused drugs in the country, more than heroin, more than cocaine. Patients can sell them off a few at a time and make a few dollars.

But those sealed bottles of lifesaving AIDS medication that net thousands of dollars have another destination. They go out of the country, to eager markets in the Caribbean and elsewhere in the developing world. There the seals will be broken and the pills will be taken by desperate men and women who want to live. A reporter for Mother Jones painstakingly traced this modern trade route a few years ago, from the patients selling their pills along Ninth Avenue to a doctor in the Dominican Republic slipping patients a contact number to buy the drugs. “It is something I cannot fight,” the doctor said. “People want to live.”

At these international conferences many of the delegates are H.I.V. infected and, by definition, healthy, or at least well enough to travel. Periodically a presenter will show videos of the sick ones back at home: skeletal before the drugs arrive; weeping with joy and gratitude afterward.

And I think of Ralph: his luck, his profligacy, and the fact that in a way he is actually doing more for the international effort than I am. Or, in a strange way, helping me do my part.

Ralph is a tough nut to crack. He has been through many doctors — all ringing his death knell in ever more emphatic tones — and doesn’t pay much attention to the lectures any more. His health seems to be pretty good. He is a little overweight and his legs hurt, but he hasn’t been hospitalized in years. If my experience with patients like him over the years is any guide, he will change his modus operandi only when he does become as skeletal and desperately ill as the people in those videos.

Or, perhaps, his life will be saved in another way. When the world’s supply of lifesaving meds expands enough, the middleman on the corner will no longer interested be in Ralph’s small contribution. Then he will have to take those meds himself. Think of it, Mr. Gates and Mr. Clinton, all you folks at Pepfar and Unaids, all you big hearts and big pockets of the world: among the lives you save will be Ralph’s.

Dr. Abigail Zuger, who writes the monthly Books column, is an infectious-disease physician in Manhattan.

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A new analysis has concluded that controversial zinc nasal gel products can indeed cause some patients to lose their sense of smell.

The Food and Drug Administration last year warned consumers to stop using Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Nasal Swabs, popular homeopathic remedies which contain zinc. Matrixx Initiatives of Scottsdale, Ariz., which markets the products, has denied the zinc gels cause anosmia, and called the conclusions “scientifically unfounded and misleading,” but the company did recall both products, which have been the subjects of hundreds of lawsuits.

The new study was published in the Archives of Otolaryngology – Head & Neck Surgery.

The authors, Dr. Terence M. Davidson and Dr. Wendy M. Smith applied nine criteria used in 1965 by Sir Austin Bradford Hill to demonstrate a causal link between smoking and lung cancer. The Bradford Hill criteria include an examination of the strength of the association between the risk factor and the disease, as well as the consistency, specificity, relationship in time, biological plausibility and experimental evidence, and whether greater exposure is associated with more disease.

Dr. Davidson, director of the nasal dysfunction clinic at the University of California, San Diego, said there is no danger from zinc gluconate taken orally but said that when it is sniffed through the nose it can burn olfactory tissue.

Bill Hemelt, chief executive of Matrixx Inc., said the product was safe. “The common cold is the number one cause of loss of sense of smell, and naturally people who use the product and have a cold are misattributing the result to our product.”

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